MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550310
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a cre- pulmonary dilatation balloon was used in the main airway during a balloon dilation procedure performed on (b)(6) 2022.During the procedure, the balloon reached the stenosis in the main airway, but burst when they applied pressure.The customer stated that no pieces of the balloon detached inside the patient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation result the returned cre pulmonary dilatation balloon was analyzed and a visual examination found that the balloon was torn longitudinally.Microscopic inspection confirmed the balloon had a longitudinal tear.The catheter of the device was carefully inspected and no damages were found.No other problems with the device were noted.Media inspection of the photos provided by the customer show the device and pouch but no damages were observed.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The balloon longitudinal tear could have been interpreted by the customer as the reported event of balloon burst.This failure is likely to have occurred due to factors encountered during the procedure, such as excess pressure, interaction with other devices, or anatomical factors.It is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon, causing a longitudinal tear.Demonstrating excessive force during handling or usage and/or forcing the device against significant resistance could result in device damage or loss of functionality.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre- pulmonary dilatation balloon was used in the main airway during a balloon dilation procedure performed on (b)(6) 2022.During the procedure, the balloon reached the stenosis in the main airway, but burst when they applied pressure.The customer stated that no pieces of the balloon detached inside the patient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15846032
• Report Number: 3005099803-2022-06825
• Device Sequence Number: 12257687
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: M00550310
• Device Catalogue Number: 5031
• Device Lot Number: 0027226575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG